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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION, 50MM

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ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION, 50MM Back to Search Results
Model Number 25001050E
Device Problems Mechanical Problem (1384); Insufficient Information (3190)
Patient Problems Joint Dislocation (2374); Insufficient Information (4580)
Event Date 04/22/2021
Event Type  Injury  
Manufacturer Narrative
The male-female midsection component was revised during a revision surgery. The sales representative stated that the patient pulled out the surgical drain after the prior surgery. He reported that this led to a revision surgery where the male-female midsection was revised. He stated that there was no failure of the male-female midsection component. No other information is available at this time. If more information is obtained, a supplement report will be submitted, multiple mdrs were submitted for this event: 3013450937-2021-00084, 3013450937-2021-00085, 3013450937-2021-00086, 3013450937-2021-00088, 3013450937-2021-00089, 3013450937-2021-00090, 3013450937-2021-00091.
 
Event Description
The patient involved in this complaint underwent a revision surgery on (b)(6) 2021 performed by dr. (b)(6). It was reported by the sales representative that the patient pulled out their surgical drain when the drain was supposed to remain in the patient according to post-operative instructions. The drain was placed on (b)(6) 2021 during a surgery performed by dr. (b)(6) to place eleos components for an unknown reason. During the revision surgery, the patient had eleos components explanted and replaced. There was no reported failure of the eleos components. It is unknown at this time why the components were replaced. No further information is available at this time.
 
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Brand NameELEOS
Type of DeviceMALE-FEMALE MIDSECTION, 50MM
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
jonathan zachok
77 east halsey road
parsippany, NJ 07054
MDR Report Key11866621
MDR Text Key252137796
Report Number3013450937-2021-00087
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25001050E
Device Catalogue Number25001050E
Device Lot Number1873152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/21/2021 Patient Sequence Number: 1
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